The Trial Master Files Record Specialist manages the Electronic Trial Master File (eTMF) for clinical trials, ensuring compliance with protocols and regulations, oversees record-keeping, supports trial teams, and contributes to audits and inspections. They maintain close communication with clinical trial teams and oversee the close-out process of trial master files after completion.

The Trial Master Files Record Specialist is responsible for managing electronic trial master files (eTMF), ensuring compliance with regulations, maintaining trial records, and supporting audits. They collaborate with the trial team to oversee TMF activities, manage trial-specific documentation, and ensure timely and accurate reporting of TMF metrics. The role involves continuous communication with trial teams and may include contributing to non-trial projects as assigned.

The Senior Quality Assurance Auditor will lead, plan, perform, and report GxP audits across all phases of Clinical Research, ensuring compliance with Good Practices. Responsibilities include mentoring staff, optimizing processes, supporting investigations, and providing consultancy on regulatory compliance.